Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Wednesday, March 26, 2008

Baxter Executives and the Syndrome of Overconfidence in a Chinese Pigsty

At various posts on Baxter's contaminated heparin, Roy Poses makes a number of good points. I will amplify one I consider crucial, and perhaps sentinel:

Yet Baxter International executives have not exactly been jumping forward to claim responsibility. In a letter, again to the Chicago Tribune, Peter J Arduini, President, Medication Delivery, for Baxter International seemed to be deflecting responsibility towards Scientific Protein Laboratories and the FDA, while asserting Baxter did all it could do.

How could Arduini know "Baxter did all it could do" to assure the quality of a complex biological?

Note his corporate bio below. Anything missing? How about:

A scientific background - such as in chemistry, biology, pharmacology, biomedicine, fields like that? Maybe a BA, or better yet, an MS, or how about ... a PhD in some scientific area?

He seems to have no personal knowledge or professional credentials that would permit him to understand the fine points of drug/biological manufacturing and purity.

However, by his executive position he held the ultimate responsibility to understand and act on this issue, and in my opinion should face the consequences of that responsibility. From my perspective (and not just a personal one; I was once Director of the team that authors The Merck Index of Chemicals, Drugs and Biologicals), the following questions should be asked:

Were there complaints from people with a science background at Baxter about the risks of acquiring heparin ingredients from fuzzy Chinese sources, that were ignored or even punished?

Why was someone with no biomedical background in such a position?

As President, Medication Delivery, what does Arduini's employment contract state with regard to his responsibilities to assure drug quality and purity?

If his job description includes that function, why is he not being held accountable?

If his job description does not include issues of product quality and purity, then why not, and ... whose does?

What was the role of the Baxter Board of Directors in setting professional and educational criteria for top executives responsible for drugs and biologicals?

Did Board members have any conflicts of interest regarding such matters?

Once again, it seems we have at the very least a management expertise problem, as pointed out in many stories on HCRenewal:

Peter J. Arduini is corporate vice president of Baxter Healthcare Corporation and president of the company's Medication Delivery business .

Prior to joining Baxter in March 2005, Mr. Arduini served as global general manager of General Electric Healthcare ' s cat scan (CT) and functional imaging business, a $2 billion capital equipment and innovation-intensive business. Mr. Arduini spent 15 years at General Electric Healthcare in a variety of management roles for domestic and global businesses. In addition to having served in sales management there, he also oversaw marketing, market research, product design and engineering program development for its radiology and cardiology franchise. Prior to joining General Electric Healthcare, Mr. Arduini spent four years with Procter & Gamble.

Mr. Arduini received his bachelor's degree in marketing from Susquehanna University and a master's in management from Northwestern University's Kellogg School of Management.

Regarding simple common sense, let alone scientific credentials:

Considering the low quality of much of the electronics I buy stamped "Made in China", where I usually buy two of everything (so I can return the one that's broken right out of the box), I'd say the Baxter execs should have been suspicious by default about the heparin ingredients. Suspicious with regard not just to adulteration and counterfeiting (which China seems excellent at - think CD's and designer watches), but to basic impurities, period.

After all, these came not from a foreign electronics company, but from a foreign pigsty.

That is not exactly a place that inspires my confidence regarding medication purity issues.

If I had been that President for Medication Delivery, I'd have set up the most rigorous, analytical chemistry-based and on-site inspection quality assurance program from the get-go. I'd have refused to outsource to China without that. To hell with FDA.

However, that awareness requires two things: brains, along with the appropriate scientific education and expertise (to realize the need), and money (which cuts profits.)

I am tired of the "leadership by biomedical dilettante" that plagues healthcare. Baxter's senior executives and Board deserve to be sued in my opinion by those harmed. Such devastating lawsuits will send a needed corrective message.

I also extend an offer of my knowledge and services to plaintiff's attorneys in that regard.

One further thought: in this age where tort lawyers are constantly portrayed as clogging the court system with frivolous lawsuits, and responsible (by their very litigiousness) for the high cost of medical care, I must inquire: where IS this cadre of attorneys--the last, best hope for corrective behavior?--Melody

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